Phentermine Hydrochloride (FEN-ter-meen hye-droe-KLOR-ide), Topiramate (toe-PIR-a-mate)

Used with diet and exercise to help you reach and maintain a healthy weight.

Brand Name(s):

Qsymia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Carefully follow your doctor's instructions about diet and exercise.
• Take this medicine in the morning, with or without food. It might keep you awake if you take it at night.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose or forget to take your medicine, skip the missed dose. Take your regular dose the next morning. Do not take extra medicine to make up for the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor (MAOI) within the past 14 days.
• Some medicines can affect how phentermine/topiramate works. Tell your doctor if you are using the following:
  • Acetazolamide, amitriptyline, dichlorphenamide, methazolamide, pioglitazone, zonisamide
  • Birth control pills
  • Other diet pills (including nonprescription or herbal products)
  • Diuretic (water pill)
  • Medicine to treat seizures (including valproic acid, carbamazepine, phenytoin)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. You should have a negative pregnancy test before you start taking this medicine and every month during treatment. Tell your doctor right away if you miss a period.
• Tell your doctor if you have kidney disease, liver disease, diabetes, eye problems, heart failure, heart rhythm problems, seizures, or a history of depression, stroke, or heart attack.
• Do not breastfeed during treatment with this medicine.
• This medicine could cause the following problems:
  • Increased heart rate
  • Changes in mood or behavior, including thoughts of suicide
  • Eye pain or vision changes, including glaucoma
  • Metabolic acidosis (too much acid in the blood)
  • Decreased bone density
  • Slow growth in children
  • Changes in blood sugar levels
  • Changes in body temperature
  • Kidney stones
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis
• This medicine may cause you to feel dizzy, drowsy, or confused, or to have trouble thinking or speaking. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely. You might have a seizure if you stop taking the medicine too fast.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or cloudy urine, painful urination, sudden lower back or stomach pain
• Changes in vision, eye pain
• Decreased sweating, fever, or feeling hot
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting
• Fast breathing, loss of appetite, unusual tiredness
• Fast, pounding, or uneven heartbeat
• Feeling agitated, depressed, nervous, or irritable, thoughts of hurting yourself or others, unusual mood or behavior
• Lightheadedness, dizziness, or fainting
• Problems with speech or memory, trouble concentrating, confusion
• Seizures

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Metallic taste in your mouth
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088